Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia (BERSON)

Amgen

Status and phase: Completed; Phase 3

Conditions: Diabetes, Hyperlipidemia, Mixed Dyslipidemia

Treatments: Biological: Evolocumab; Drug: Atorvastatin; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02662569

20120119

2013-000723-14 (EudraCT Number)

Details and patient eligibility

About

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.

Enrollment: 986 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy
• Lipid-lowering therapy must be unchanged for at least 4 weeks or more
• Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL
• Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL

Exclusion criteria

• New York Heart Association (NYHA) class III or IV heart failure
• Uncontrolled cardiac arrhythmia
• Uncontrolled hypertension
• Type 1 diabetes or poorly controlled type 2 diabetes
• Uncontrolled hypothyroidism or hyperthyroidism.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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986 participants in 4 patient groups

Atorvastatin (Q2W)

Active Comparator group

Description:

Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and 20 mg atorvastatin orally once a day for up to 12 weeks.

Treatment:

Other: Placebo

Drug: Atorvastatin

Atorvastatin (QM)

Active Comparator group

Description:

Participants received placebo subcutaneous injection once a month (QM) and 20 mg atorvastatin orally once a day for up to 12 weeks.

Treatment:

Other: Placebo

Drug: Atorvastatin

Evolocumab Q2W + Atorvastatin

Experimental group

Description:

Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and 20 mg atorvastatin orally once a day for up to 12 weeks.

Treatment:

Drug: Atorvastatin

Biological: Evolocumab

Evolocumab QM + Atorvastatin

Experimental group

Description:

Participants received 420 mg evolocumab by subcutaneous injection once a month and 20 mg atorvastatin orally once a day for up to 12 weeks.

Treatment:

Drug: Atorvastatin

Biological: Evolocumab